New Drug Approvals

Good News For Pfizer’s Orphan Drug Bosulif (Bosutinib) in Europe

BOSUTINIB
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile

 

mar 28,2013

Regulators in Europe have given a partial green light to Pfizer ‘s leukaemia drug Bosulif.

The European Commission has granted conditional marketing authorisation for Bosulif (bosutinib) for the treatment of adults with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia (CML). The drug can be given to patients previously treated with one or more tyrosine kinase inhibitors ie Novartis’ Gleevec (imatinib) and Tasigna (nilotinib) or Bristol-Myers Squibb’s Sprycel (dasatinib).

The European Medicines Agency’s  (EMA) Committee for Medicinal Products for Human Use (CHMP) on January 17, 2013, adopts a positive opinion, recommending a conditional marketing authhorization for Pfizer’s orphan drug Bosulif (Bosutinib) for Chronic Leukemia (CML).  Bosutinib receives orphan designation from the European Commission (EC) on August 4, 2010, for CML.

https://docs.google.com/viewer?url=http%3A%2F%2Fwww.ema.europa.eu%2Fdocs%2Fen_GB%2Fdocument_library%2FSummary_of_opinion_-_Initial_authorisation%2Fhuman%2F002373%2FWC500137464.pdf

Pfizer receives FDA approval on September 4, 2012, for orphan drug Bosulif (Bosutinib) for CML…

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About luciavazine

PHARMA PROFESSIONAL, ITALY
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